Data Foundry

Medical device recalls 2023

4500MD Triple Quad Mass Spectrometer — Class II medical device recall Z-0038-2024

Ongoing recall by AB Sciex, LLC, reported 2023-10-11, distributed nationwide. In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an ele

Recall numberZ-0038-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAB Sciex, LLC, Framingham, MA, United States
Recall initiated2023-08-30
Classified2023-10-05
Reported by FDA2023-10-11
DistributedNationwide (US)
Quantity38
Reason classespackaging
UPC / GTIN / UDI-DI00842365102049
Serial numbersEJ230051806PL, EJ230061807PL, EJ230071808, EJ230101810, EJ230111811, EJ230121811, EJ230141811, EJ230151812, EJ230161812, EJ230171901, EJ230181901, EJ230191901, EJ230211905, EJ230221908, EJ230231908, EJ230251909, EJ230271910, EJ230281910, EJ230311911, EJ230331912, EJ230362003, EJ230372003, EJ230392004, EJ230412009, EJ230422011 and 13 more
Model numbers5032522

Product

4500MD Triple Quad Mass Spectrometer, Part Number 5032522

Reason for recall

In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0038-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.